March 22, 2013
Pfizer issued a warning that rifampin injection 600 mg vials and Novaplus rifampin injection 600 mg vials may be discolored. All available lots of these products are included in this warning. Lyophilized powder in the affected vials is described as brown or black in color, rather than the normal red coloration. The resulting reconstituted solution of affected vials will also appear discolored. The clinical effects of these color changes are not known at this time, but Pfizer warns that potency or purity of the product may be affected.
Examine rifampin vials and infusion solutions prior to dispensing or administering. Pictures of normal and discolored product are available in a Dear Healthcare Professional letter issued by Pfizer. Discard any discolored product according to institutional policies. Report discolored product to Pfizer Safety (800-438-1985). Normally colored rifampin injection may continue to be used.
FDA encourages consumers and healthcare professionals to report adverse reactions to FDA’s MedWatch Program at www.fda.gov/medwatch.
- Dear Healthcare Professional Letter:
March 22, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.